BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOLEY CATHETER, 16 F

    MDR report key: 2630779 · Received June 20, 2012

    Report

    Report Number
    1417592-2012-00048
    Event Type
    Other
    Date Received
    June 20, 2012
    Date of Event
    May 16, 2021
    Report Date
    June 15, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A HOME HEALTH NURSE WAS UNABLE TO DEFLATE THE BALLOON OF A SUPRAPUBIC CATHETER IN PREPARATION FOR THE CATHETER'S REMOVAL. THE PATIENT WAS SENT TO THE ER AND THE PATIENT WAS ASKED TO RETURN THE NEXT DAY SO THAT THE UROLOGIST COULD CHANGE THE CATHETER. THE CATHETER WAS CHANGED WITHOUT INJURY TO THE PATIENT. WHEN THE DEFLATION CONCERN WAS IDENTIFIED, IT IS NOT KNOWN IF THE BALLOON INFLATION PORT WAS CUT TO ALLOW THE BALLOON TO PASSIVELY DEFLATE ON ITS OWN AND ALLOW FOR THE CATHETER REMOVAL. IT IS ALSO NOT KNOWN WHY THE CATHETER CHANGE WAS NOT PERFORMED DURING THE ER VISIT. NO ADDITIONAL DETAILS WERE PROVIDED. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. AN UNUSED SAMPLE WAS RETURNED BY THE END USER. THE BALLOON WAS TESTED. IT INFLATED AND DEFLATED WITH THE AID OF A SYRINGE. WE COULD NOT DUPLICATE THE REPORTED CONCERN. WE HAVE NO TREND FOR THIS ISSUE WITH THIS CATHETER. A ROOT CAUSE WAS NOT DETERMINED AND NO CORRECTIVE ACTION IS BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    BALLOON OF FOLEY WOULD NOT DEFLATE AND REQUIRED INTERVENTION OF UROLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER, 16 F EZL MEDLINE INDUSTRIES, INC. 11CB2782

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention